SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma. The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled. The purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Osoby w wieku 18 lat lub starsze.
- •Pacjent musi mieć potwierdzony guz mózgu (glejak) z mutacją IDH1.
- •Guz musi być w stadium 2 lub 3, lub z cechami wysokiego ryzyka, lub w stadium 4 (w zależności od części badania).
- •Pacjent musiał przejść maksymalnie 2 wcześniejsze terapie z powodu nawrotu lub postępu choroby.
- •Pacjent musi mieć guz widoczny na badaniach obrazowych, o określonych wymiarach.
- •Pacjent musi mieć prawidłowe wyniki badań krwi i narządów.
- •Pacjent musi wyrazić zgodę na oddanie tkanki guza do badań (w części 2 i 3).
✗ Disqualifies
- •Niektóre wcześniejsze terapie mogą wykluczać z udziału w badaniu.
- •Obecność innych nowotworów.
- •Ciąża lub karmienie piersią.
- •Znaczne problemy z sercem, nerkami lub wątrobą.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 1, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (57)
University of Alabama
Birmingham, United States
Mayo Clinic - Arizona
Phoenix, United States
St. Joseph's Hospital and Medical Center
Phoenix, United States
University of California San Diego
La Jolla, United States
University of California, Los Angeles
Los Angeles, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, United States
Stanford University
Palo Alto, United States
University of California
San Francisco, United States
University of Colorado Health Cancer Care
Aurora, United States
Yale University
New Haven, United States
University of Florida Health
Gainesville, United States
Mayo Clinic - Florida
Jacksonville, United States
University of Miami Health
Miami, United States
Orlando Health Cancer Institute
Orlando, United States
University of Chicago
Chicago, United States
Indiana University
Indianapolis, United States
University of Kansas Medical Center
Kansas City, United States
Massachusetts General Hospital
Boston, United States
Dana-Farber Cancer Institute
Boston, United States
Henry Ford Hospital
Detroit, United States
Mayo Clinic - Rochester
Rochester, United States
Washington University
St Louis, United States
Billings Clinic
Billings, United States
Rutgers Cancer Institute
New Brunswick, United States
NYU Langone Health
New York, United States
Icahn School of Medicine at Mount Sinai
New York, United States
Columbia University Medical Center
New York, United States
Memorial Sloan Kettering Cancer Center
New York, United States
University of Rochester Medical Center
Rochester, United States
Duke Cancer Institute
Durham, United States
Cleveland Clinic
Cleveland, United States
Thomas Jefferson University Hospital
Philadelphia, United States
UPMC Hillman Cancer Center
Pittsburgh, United States
Vanderbilt-Ingram Cancer Center
Nashville, United States
University of Texas Southwestern Medical Center
Dallas, United States
MD Anderson Cancer Center
Houston, United States
Mays Cancer Center
San Antonio, United States
Huntsman Cancer Insititute, University of Utah
Salt Lake City, United States
UVA Health, Emily Couric Clinical Cancer Cente
Charlottesville, United States
Inova Schar Cancer Institute
Fairfax, United States
Fred Hutch Cancer Center
Seattle, United States
University of Wisconsin Health
Madison, United States
St Vincents Hospital Sydney (Kinghorn)
Darlinghurst, Australia
Royal North Shore Hospital
Saint Leonards, Australia
Royal Brisbane and Women's Hospital
Herston, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
The Alfred
Melbourne, Australia
Sir Charles Gairdner Hospital
Nedlands, Australia
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
Sanbo Brain Hospital, Capital Medical University
Beijing, China
Xuanwu Hospital, Capital Medical University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Xiangya Hospital of Central South University
Changsha, China
Huashan Hospital Affiliated to Fudan University
Shanghai, China
West China Hospital of Sichuan University
Chengdu, China
Trial contact
Clinical Trials at Nuvation Bio
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.